Self-care Intervention for Reducing Rehospitalization for Heart Failure: a Randomized Clinical Trial (SIHF)

NCT04870918 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-06-29

No results posted yet for this study

Summary

Introduction: Heart failure (HF) is considered an epidemic with high morbidity and mortality that imposes limitations on affected individuals, decreases the quality of life, restricts social life and makes it difficult to carry out daily activities including work. Almost 50% of diagnosed patients are readmitted in less than 90 days after discharge. Therefore, rehospitalization is considered as a predictive cause of the increased risk of intrahospital death in patients hospitalized with HF due to underlying disease. Related to chronic diseases, self-care is essential in maintaining physical and psychological well-being because it corroborates the success of the treatment. The patient's observational and resolving capacity is necessary in view of the appearance of signs and symptoms that would be postponed or alienated and would end up in hospital. Objective: To verify whether an intervention focused on self-care reduces the number of readmissions, improves quality of life and provides greater post-traumatic growth in patients with HF. Method: Randomized clinical trial, parallel by intention to treat, with blinding for evaluation of outcomes. Adult patients who were admitted to a Hospital in the Serra Gaúcha and who were identified as having HF by the attending physician will be included. Upon discharge, patients will leave the hospital with a date and time to return to the HF Ambulatory. In the first consultation, patients will be invited to participate in the study and will answer a nursing screening instrument and the following instruments: WHOQOL-BREF and ICPT (respectively, quality of life and post-traumatic growth). In order of date and time when signing the informed consent form, patients will be randomized in 1: 1. From the second consultation, the intervention group will be followed up for guidance on the disease and treatment, totaling 12 sessions in 6 months. The control group will go through medical consultations as instructed by the doctor and will not receive intervention for health education by the nurse. After the end of the treatment, the patients will be followed in order to verify the occurrence of new hospitalizations in 6 months and in 1 year. At the end of 1 year the instruments will be replicated. Results: It is expected to enable the patient to remain free of the symptoms of the disease, following the prescribed treatment and being able to recognize any changes that signal an aggravation of the disease. It is hoped that the intervention in health education can decrease the rate of rehospitalization of patients, improve the quality of life and provide greater post-traumatic growth in patients with HF.

Conditions

Interventions

BEHAVIORAL

self-care intervention

Health education will be carried out by the nurse.

Sponsors & Collaborators

  • Universidade de Caxias do Sul

    collaborator OTHER
  • Instituto de Cardiologia do Rio Grande do Sul

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2021-06-01
Completion
2021-06-01

Countries

  • Brazil

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04870918 on ClinicalTrials.gov